FDA Label for Childrens Pain Relief
View Indications, Usage & Precautions
- DRUG FACTS
- PURPOSE
- USES
- WARNINGS
- DO NOT USE
- ASK A DOCTOR BEFORE USE IF YOUR CHILD HAS
- ASK A DOCTOR OR PHARMACIST BEFORE USE IF YOUR CHILD IS
- STOP USE AND ASK A DOCTOR IF
- KEEP OUT OF REACH OF CHILDREN.
- DIRECTIONS
- OTHER INFORMATION
- INACTIVE INGREDIENTS
- QUESTIONS OR COMMENTS?
- PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 160 MG (24 CHEWABLE TABLETS BLISTER CARTON LABEL)
Childrens Pain Relief Product Label
The following document was submitted to the FDA by the labeler of this product Better Living Brands, Llc. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Drug Facts
Active ingredient (in each tablet)
Acetaminophen USP 160 mg
Purpose
Pain reliever/fever reducer
Uses
- temporarily relieves minor aches and pains due to:
- the common cold
- flu
- headache
- sore throat
- toothache
- temporarily reduces fever
Warnings
Liver warning:This product contains acetaminophen. Severe liver damage may occur if your child takes:
- more than 5 doses in 24 hours, which is the maximum daily amount
- with other drugs containing acetaminophen
- skin reddening
- blisters
- rash.
Allergy alert:acetaminophen may cause severe skin reactions. Symptoms may include:
If a skin reaction occurs, stop use and seek medical help right away.
Sore throat warning:
if sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly.
Do Not Use
- with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
- if your child is allergic to acetaminophen or any of the inactive ingredients in this product
Ask A Doctor Before Use If Your Child Has
liver disease.
Ask A Doctor Or Pharmacist Before Use If Your Child Is
taking the blood thinning drug warfarin.
Stop Use And Ask A Doctor If
- pain gets worse or lasts more than 5 days
- fever gets worse or lasts more than 3 days
- new symptoms occur
- redness or swelling is present
These could be signs of a serious condition.
Keep Out Of Reach Of Children.
Overdose warning:In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222)
Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.
Directions
- this product does not contain directions or complete warnings for adult use.
- do not give more than directed (see overdose warning)
- chew tablets completely before swallowing; do not swallow tablets whole
- find right dose on chart below. If possible, use weight to dose; otherwise, use age
- repeat dose every 4 hours while symptoms last
- do not give more than 5 times in 24 hours
Weight (lb) | Age (yr) | Dose (tablets)* |
under 24
| under 2 years
| ask a doctor
|
24 to 35
| 2 to 3 years
| 1 tablet
|
36 to 47
| 4 to 5 years
| 1½ tablets
|
48 to 59
| 6 to 8 years
| 2 tablets
|
60 to 71
| 9 to 10 years
| 2½ tablets
|
72 to 95
| 11 years
| 3 tablets
|
*or as directed by a doctor
Other Information
- store between 20° to 25°C (68° to 77°F). Avoid high humidity. Protect from light.
- do not use if carton is open or if printed seal on blister is broken or missing.
Inactive Ingredients
citric acid anhydrous, colloidal silicon dioxide, copovidone, crospovidone, D&C red No. 27 lake, D&C red 30 aluminum lake, dextrose monohydrate, ethylcellulose, flavor, magnesium stearate, mannitol, sodium starch glycolate, stearic acid, sucralose.
Questions Or Comments?
call 1-855-274-4122
DISTRIBUTED BY:
BETTER LIVING BRANDS LLC
P.O.BOX 99 PLEASANTON,
CA 94566-0009
‡1-888-723-3929
Made in India
Code: TS/DRUGS/16/2014
Package Label-Principal Display Panel - 160 Mg (24 Chewable Tablets Blister Carton Label)
Signature
care
®
Quality
Guaranteed
Compare to the
Children's Tylenol
®
Chewables
active ingredient
**
NDC 21130-223-76
AGES 2-11
DO NOT USE WITH OTHER MEDICINES
CONTAINING ACETAMINOPHEN
Childrens’s
Pain Relief
Acetaminophen Chewable Tablets 160 mg
Pain Reliever/Fever Reducer
• Aspirin Free
• Ibuprofen Free
BUBBLE GUM
Flavor
Actual Size
24 CHEWABLE TABLETS
160 mg each
* Please review the disclaimer below.